Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Detection of Enterovirus RNA in Atheromatous Lesions (ATH-ENTE)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00674531
First received: May 7, 2008
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

Atherosclerosis is one of the first causes of morbidity-mortality in industrialized countries. Numerous works suggest that some infectious agents could be involved in the inflammatory process leading to the development of this pathology, such as Chlamydophila pneumoniae, cytomegalovirus or herpes simplex virus. Enteroviruses are small RNA viruses that have been incriminated in various acute or chronic cardiac diseases (pericarditis, myocarditis, dilated cardiomyopathy) and exhibit a tropism for vascular endothelia. Different clinical and experimental arguments suggest that they could play a cofactor role in the occurrence or maintenance of atherosclerosis lesions. A multicenter study developed in collaboration with colleagues of the University Hospital of Reims (France) showed that it was frequent to detect enterovirus RNA in cardiac biopsies from patients with myocardial infarction. Furthermore, a pilot study conducted in the University Hospital of Saint-Etienne (France) on atheromatous arterial samples from 18 patients allowed the detection of enterovirus RNA in 20% of them.


Condition Intervention
Arteriosclerosis
Procedure: Artery resection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Detection of Enterovirus RNA by RT-PCR in Atheromatous Lesions

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Prévalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound carotid artery [ Time Frame: artery resection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound vein [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of enteroviral RNA by RT-PCR in sound carotid artery in comparison with sound vein [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of enteroviral RNA by RT-PCR in calm and active atherosclerotic lesions [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of antibodies between different groups of patients. [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with circulating blood [ Time Frame: Artery resection ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Enterovirus RNA analysis
Procedure: Artery resection
Artery resection

Detailed Description:

Objective: In order to complete these data and to answer clearly to the question of the role of persistent infection by enteroviruses in atherosclerosis, we propose this research program involving the Departments of Vascular Surgery of three University hospitals of the "Rhône-Alpes" region and of three laboratories of Virology interested by the relationship between chronic diseases and enterovirus infection..

Methods: It is projected to include about one hundred voluntary adults exhibiting carotid atheromatous lesions requiring a surgical removal. Because of the difficulty to define a pertinent control group, each patient will be his/her own control. In addition to the fragment of pathologic carotid, it will be taken arterial and venous fragments from vessels that are never the seat of atherosclerosis lesions. To reach the best sensitivity, enterovirus RNA will be detected by nested RT-PCR.

Evaluation criteria: The main evaluation criterion will be the percentage of detection of enterovirus RNA by RT-PCR in atheromatous lesions by comparison to control arteries by Mac-Nemar test. These results will be correlated to anatomic and histological lesions of the atheromatous plaques. Other markers will be analysed secondarily: detection of enterovirus RNA in control venous samples, detection of stigmata of viral replication by immunochemistry or detection of negative RNA strands, analysis of the antibody response to enterovirus in blood, molecular typing of enteroviruses detected in the lesions… Expected benefits: This study should allow to better understand the putative involvement of enteroviruses in atherosclerosis-linked diseases. If the hypothesis of a relationship was confirmed, a more ambitious research project would be proposed in order to investigate the mechanisms by which enterovirus can favour atherosclerosis and to discuss the opportunity of preventive strategies (notably vaccination) to reduce the risk.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication of artery resection
  • affiliated or a beneficiary of a social security category
  • having signed the inform consent form

Exclusion Criteria:

  • pregnant women
  • contra-indication to clamping
  • scheduled resection at friday after-noon, week-end or legal holidays
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674531

Locations
France
CHU de Clermont-Ferrand
Clermont-ferrand, France, 63000
CHU de Grenoble
Grenoble, France, 38000
CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Xavier BARRAL, MD PhD CHU de Saint-Etienne
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00674531     History of Changes
Other Study ID Numbers: 0608071, 2007-A00895-48, DGS2007-0534
Study First Received: May 7, 2008
Last Updated: October 8, 2014
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Arteriosclerosis
Arterial Occlusive Diseases
Enterovirus
Artery resection

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Enterovirus Infections
Arterial Occlusive Diseases
Cardiovascular Diseases
Picornaviridae Infections
RNA Virus Infections
Vascular Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014